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Rusfertide granted breakthrough therapy designation by the FDA for erythrocytosis in PV
On August 25, 2025, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to rusfertide, a first-in-class investigational hepcidin-mimetic peptide, for the treatment of erythrocytosis in patients with polycythemia vera (PV).¹
Breakthrough therapy designation was granted based on 32-week data from the ongoing phase III VERIFY study (NCT05210790), which is evaluating the safety and efficacy of once-weekly, self-administered, subcutaneous rusfertide over 156 weeks in 293 patients with PV and uncontrolled hematocrit who are phlebotomy dependent. The MPN Hub has previously reported the results from Part 1a of the study.
Rusfertide was previously granted orphan drug designation and fast track designation for the treatment of PV in 2020 by the FDA.
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What would be your preferred strategy to treat patients with newly diagnosed MF with moderate anemia (Hb <10 g/dL) and platelet count <200,000/µL?
